A comparison of 2 medicine, for spinal anesthesia in lower limb surgeries in adult patients.

A randomized comparative study between hyperbaric levobupivacaine and hyperbaric levobupivacaine with dexmedetomidine in lower limb surgeries in adult patients under subarachnoid block - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088874

Enrollment

Registered

2025-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S82- Fracture of lower leg, including ankle Health Condition 2: S82- Fracture of lower leg, including ankle

Interventions

Intervention1: Subarachnoid block: Drug is given in Lumber 3rd and lumber 4th intervertebral subarachnoid space in all participants of the study. Onset and duration of sensory and motor blockade evalu

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1 and 2, age 18-65 years of either sex, patient undergoing elective lower limb surgeries.

Exclusion criteria

Exclusion criteria: Patient refusal, ASA grade 3 and 4, known allergy or hypersensitivity to local anaesthesic drugs, infection at the injection site, bleeding diathesis or coagulopathy, pre existing ischaemic heart disease, diabetes mellitus and hypertension, CNS disorder-epilepsy and raised intracranial tension, severe renal, hepatic, hematological, metabolic disorder, cardiac malformation, spinal deformity, pregnancy, COPD, Asthma, chronic bronchitis.

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the efficacy of the drugsTimepoint: Onset of sensory and motor blockade will be assessed at different time intervals till the complete effect or for 30 minutes after injection.	—

Secondary

Measure	Time frame
To compare and evaluate onset and duration of sensory block in both the groups, to compare and evaluate onset and duration of motor block in both groups.Timepoint: Sensory and motor blockade will be evaluated every 1 minute for initial 5 min and every 2 min for next 10 min till the complete effect.;Hemodynamic changes if any- heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2.Timepoint: Heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2 will be recorded immediately after procedure and every 2 min for initial 10 min, every 5 min for next 30 min and at 15 min interval till completion of the surgery.;To compare and evaluate time of first rescue analgesia in both groups.Timepoint: Patient to be assessed for 12 hours for rescue analgesia;ComplicationsTimepoint: Patient to be assessed for 24 hours post operatively.	—

Measure

Time frame

To compare and evaluate onset and duration of sensory block in both the groups, to compare and evaluate onset and duration of motor block in both groups.Timepoint: Sensory and motor blockade will be evaluated every 1 minute for initial 5 min and every 2 min for next 10 min till the complete effect.;Hemodynamic changes if any- heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2.Timepoint: Heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2 will be recorded immediately after procedure and every 2 min for initial 10 min, every 5 min for next 30 min and at 15 min interval till completion of the surgery.;To compare and evaluate time of first rescue analgesia in both groups.Timepoint: Patient to be assessed for 12 hours for rescue analgesia;ComplicationsTimepoint: Patient to be assessed for 24 hours post operatively.

—

Countries

India

Contacts

Public ContactDr Biruj Mahalia

Lala Lajpat Rai Memorial Medical College

nickysangeeta78@gmail.com9568766156

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026